Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

NCT ID: NCT04727931

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2026-02-01

Brief Summary

A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.

The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.

Conditions

Epilepsy; Cognition

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Newly diagnosed epileptic patients

Newly diagnosed epileptic patients who have never be treated by antiepileptic drugs and who have no psychiatric (mental illness) and/or evolutive neurological history and for minor patients the non-opposition of the parental authority holders.

Neuropsychological assessement and questionnaires

Intervention Type: BEHAVIORAL

Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve.

Normal controls

Matched (on age, gender, socio-educationnal level and manual laterality) healthy controls who have no psychiatric (depression, mental illness) and/or neurological (stroke, traumatic brain injury, etc.) history and for minor patients the non-opposition of the parental authority holders.

Neuropsychological assessement and questionnaires

Intervention Type: BEHAVIORAL

Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve.

Interventions

Neuropsychological assessement and questionnaires

Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
• Person aged 16 and over
• For minor patients: the non-opposition of the parental authority holders
• Newly diagnosed epileptic patient who had never taken antiepileptic drugs.

• Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
• For minor participants: the non-opposition of the parental authority holders
• Person aged 16 and over.

Exclusion Criteria

• Person of full age who are subject to a legal protection measure or who are unable to express their consent
• Person with a progressive brain injury
• Person who regularly use psychoactive substances (cannabis, alcohol, etc.)
• Patients who started an antiepileptic treatment before the neuropsychological assessment.

• Persons of full age who are subject to a legal protection measure or who are unable to express their consent
• Person with a neurological (traumatic brain injury, stroke, etc.) and/or psychiatric (mental illness, depression, etc.) history.
• People who regularly use psychoactive substances (cannabis, alcohol, etc.).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Maillard Louis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Maillard, Pr

Role: PRINCIPAL_INVESTIGATOR

Professor of neurology

Locations

Department of neurology - Hospital of Nancy

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Natacha Forthoffer

Role: CONTACT

n.forthoffer@chru-nancy.fr

03.83.85.20.77

Facility Contacts

Forthoffer Natacha

Role: primary

n.forthoffer@chru-nancy.fr

Other Identifiers

n°2020-A00404-35

Identifier Type: -

Identifier Source: org_study_id